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October 16, 2013

Governor Brown Vetoes California Biosimilar Bill

Last week, Governor Jerry
Brown vetoed a
California bill (SB-598)
that would have authorized a pharmacist to select a biosimilar when filling a
prescription order for a prescribed biological product, provided that the
prescriber did not personally indicate "Do not substitute." The legislation would also have required that
the substitution of a biosimilar be communicated to the patient, and that the
pharmacy notify the prescriber of the substitution or enter the substitution
into a patient record within five business days of the selection. The
bill, which was introduced in February, was passed by a 60-4 vote in the
California Assembly on August 26, and by a 30-2 vote in the California Senate
on September 4.

In a letter
to the California Senate, Governor Brown (above) stated that he was
returning the legislation to the Senate without his signature because it would
"require[] pharmacists to send notifications back to prescribers about
which drug was dispensed," and "[t]his requirement, which on its face
looks reasonable, is for some reason highly controversial." Governor Brown noted that although physicians
he had spoken with "would welcome this information," the California
Public Employees' Retirement System (CalPERS), a California agency that manages
pension and health benefits for more than 1.6 million California public
employees, retirees, and their families, as well as other large purchasers had warned
the Governor that "the requirement itself would cast doubt on the safety
and desirability of more cost-effective alternatives to biologics." Because the FDA has not yet determined the standards
required for biosimilars to meet the higher threshold for interchangeability,
Governor Brown indicated that requiring physician notification at this point would
be "premature."

The Generic Pharmaceutical
Association (GPhA), which had opposed the bill, released a statement
welcoming Governor Brown's veto, which the organization said "demonstrated
compassion for millions of patients and strong fiscal stewardship for the state
of California." A statement
issued by the Biotechnology Industry Organization (BIO) provided a different
take on Governor Brown's veto, with BIO expressing disappointment that the
legislation, which "received overwhelming bipartisan approval, passing
176-13 in five committees and three floor votes in the Assembly and Senate and [which]
was supported by hundreds of patient advocate, physician, healthcare, biotech,
labor and business groups," did not receive the Governor's signature.